FDA Adverse Event
Other
Summary report: N
BIOGLUE SURGICAL ADHESIVE
MDR report key: 518147
·
Received March 29, 2004
Report
- Report Number
- 1063481-2004-00004
- Event Type
- Other
- Date Received
- March 29, 2004
- Date of Event
- January 9, 2004
- Report Date
- February 26, 2004
- Manufacturer
- CRYOLIFE, INC.
- Product Code
- MFI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ACCORDING TO INFO PROVIDED BY THE USER FACILITY, A PT OF UNK AGE AND MEDICAL HISTORY UNDERWENT SURGERY OF UNKNOWN TYPE INCORPORATING THE USE OF BIOGLUE SURGICAL ADHESIVE IN THE POSTERIOR FOSSA REGION OF THE SKULL (NOT AN APPROVED USE IN THE UNITED STATES) IN 2003. AT APPROX 4 MONTHS POST SURGERY, THE PT REQUIRED ADDITIONAL SURGERY SECONDARY TO INFECTION ASSOCIATED WITH AN UNKNOWN PATHOGEN. THE PT SUBSEQUENTLY REQUIRED 3 ADDITIONAL DAYS IN THE HOSP FOR TREATMENT OF THE INFECTION. THE INFECTION HAS SUBSIDED AND THE PT IS CURRENTLY IN GOOD CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOGLUE SURGICAL ADHESIVE | SURGICAL ADHESIVE | MFI | CRYOLIFE, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| R | NOT AVAILABLE |